Author:
Mori Kazuhiko,Toyoshima Sotoshi
Publisher
Springer Science and Business Media LLC
Subject
Pharmacology (medical),Public Health, Environmental and Occupational Health,Drug guides,Pharmacology (nursing)
Reference16 articles.
1. Pharmaceuticals and Medical Devices Agency. About PMDA objective. Available at: http://www.pmda.go.jp/englishabout/objective.html. Accessed May 1, 2008.
2. Ono S, Yoshioka C, Asaka O, Tamura K. The review of new drug applications in Japan: the decline in approval limes alter the introduction of an internalized review system. Drug Inf J. 2006;39:279–290.
3. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH harmonized tripartite guideline: ethnic factors in the acceptability of foreign clinical data (E5(R1)), step 4. February 1998. Available at: http://www.ich.org/LOB/media/MEDIA481.pdf. Accessed May 1, 2008.
4. Naito C. Necessity and requirements of bridging studies and Their present status in Japan. Int J Clin Pharmacol Ther. 2000;38(2):80–86.
5. Uyama Y, Shibala T, Nagai N, Hanaoka H, Toyoshima S, Mori K. Successful bridging strategy based on ICH ES guideline tor drugs approved in Japan. Clin Pharmacol Ther. 2005;78(2):102–113.
Cited by
7 articles.
订阅此论文施引文献
订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献